FDA UDI
In Commercial Distribution
🇺🇸 United States
AESKULISA® SS-B
DI: 04250289502986
·
Model: 7110US
·
Aesku.Diagnostics GmbH & Co. KG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- AESKULISA® SS-B
- Primary DI
- 04250289502986
- Version / Model
- 7110US
- Catalog Number
- 7110US
- Company Name
- Aesku.Diagnostics GmbH & Co. KG
- Labeler DUNS
- 341714388
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-02-28
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 8a1c9cb5-7790-4939-ab1a-fbe25e176dcc
Device Description
AESKULISA SS-B is a solid phase enzyme immunoassay employing human recombinant La-antigen/ SS-B for the quantitative and qualitative detection of antibodies against Laantigen / SS-B in human serum. The assay is a tool in the diagnosis of Sjögren`s syndrome (SS) and systemic lupus erythematosus (SLE).
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LJM | Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls | Immunology | 866.5100 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 55132 | SSB/La antibody (Sjogren's antibody) IVD, kit, enzyme immunoassay (EIA) | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of anti-SSB or anti-La antibodies (Sjogren's antibodies) in a clinical specimen, using an enzyme immunoassay (EIA) method. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04250289502986 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K032469 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius